This week, two of the F.D.A.’s top vaccine regulators announced that they would be leaving the agency this fall, apparently partly because of frustration with the administration’s booster plan. Dr. Marion Gruber, who directs the agency’s vaccines office, and her deputy, Dr. Philip Krause, have told people there was not nearly enough data to justify offering extra shots to the general population starting in just weeks.
More friction may lie ahead. On Sept. 17, the F.D.A.’s outside advisory committee is scheduled to publicly review Pfizer’s data supporting a booster shot. Even though Pfizer has asked the F.D.A. to approve booster doses for people 16 and up, the agency could decide to restrict who gets a booster. The C.D.C. and its outside advisory panel would also have to weigh in.
One key member of the F.D.A.’s advisory panel, Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, argues boosters are premature. “There is no compelling reason to get a third dose” now, he said in an interview on Thursday.
He said the administration had appeared to expect that the F.D.A. and the C.D.C. would rubber-stamp its booster timeline. “Bypassing and marginalizing those agencies led veterans who you need in this pandemic to leave the F.D.A.,” he said, referring to the departures of Dr. Gruber and Dr. Krause.
Various studies have shown that the potency of the Pfizer-BioNTech and Moderna vaccines ebbs against infection over time, but suggest that the vaccines continue to offer robust protection against severe illness and hospitalization.
But Dr. Vivek Murthy, the surgeon general, said in an interview on Thursday that a few studies have suggested a dip in protection against severe disease over time. “Our feeling was that if we waited several more months we would see protection against hospitalizations and deaths break down,” he said.
In an interview published Thursday on WebMD.com, Dr. Woodcock echoed that view, saying that the trend of breakthrough infections has led health officials to believe at some point, “we are going to see hospitalizations and more serious disease” among fully vaccinated people. When that happens, she said, “we want to be ready” with the booster plan.
Some Americans are already getting booster shots ahead of F.D.A. approval: more than a million fully vaccinated people have received an additional dose since mid-August.
